Digital Engineer - MES/Opstrakker & Werum PAS-X

JD:
Role: Digital Engineer - MES/Opstrakker & Werum PAS-X
Work location: Raritan, NJ Onsite
Contract

Job Description:
Capgemini is seeking a highly motivated Digital Engineer with 5–7 years of experience in Manufacturing Operations, Manufacturing Execution Systems (MES), and Digital Manufacturing solutions. The ideal candidate will possess hands-on experience supporting and implementing Werum PAS-X and manufacturing operations platforms such as OpsTrakker. This role will support digital transformation initiatives across life sciences, pharmaceutical, biotech, and regulated manufacturing environments by enabling operational excellence, electronic batch execution, manufacturing visibility, and compliance.
The candidate will work closely with manufacturing, quality, IT, validation, and business stakeholders to design, configure, deploy, and support MES and manufacturing operations solutions while ensuring regulatory compliance and operational efficiency.


Key Responsibilities:
MES & Manufacturing Operations Delivery
• Configure, develop, and support Werum PAS-X solutions including:
o Master Batch Records (MBRs)
o Electronic Batch Records (EBRs)
o Process workflows
o Equipment and material management
o Integration services
• Support deployment and ongoing enhancement of OpsTrakker manufacturing operations and performance management solutions.
• Analyze manufacturing business requirements and translate them into functional and technical MES solutions.
• Participate in MES implementation projects through requirements gathering, design, configuration, testing, deployment, and hypercare support.
Manufacturing Operations Integration
• Integrate MES solutions with ERP, LIMS, historians, automation systems, and shop floor applications.
• Support ISA-88 and ISA-95 aligned manufacturing architecture and data flows.
• Collaborate with production, quality, engineering, and validation teams to streamline manufacturing processes.
Support & Continuous Improvement
• Troubleshoot PAS-X and OpsTrakker application issues.
• Perform root cause analysis and implement corrective actions.
• Support production releases, upgrades, and change management activities.
• Identify opportunities for process optimization, automation, and efficiency improvements.
Documentation & Collaboration
• Create and maintain:
o Functional specifications
o Design documents
o SOPs
o Training materials
o Support documentation
• Participate in Agile delivery teams and collaborate across global stakeholders.


What are the Mandatory skills and skill proficiencies required for this position?
Education
• Bachelor's Degree in:
o Engineering
o Computer Science
o Manufacturing Engineering
o Information Systems
o Related Technical Discipline
Experience
• 5–7 years of experience in Manufacturing IT, MES, or Digital Manufacturing.
• 3 years of hands-on experience with Werum PAS-X.
• Experience supporting manufacturing operations platforms such as OpsTrakker, production tracking, or operational performance management solutions.
• Experience working within GMP regulated environments.
Werum PAS-X
• MBR/EBR development and maintenance
• PAS-X configuration and modeling
• User management and security concepts
• Material and equipment management
• Process order execution
• PAS-X troubleshooting and support
Integration Technologies
• ERP integration (SAP preferred)
• LIMS integration
• Web services/API concepts
• SQL and relational databases
• Manufacturing data interfaces


What are the Optional skills and skill proficiencies for this position?
• Experience with pharmaceutical or biotech manufacturing.
• Knowledge of ISA-88 and ISA-95 standards.
• Experience with other MES platforms such as:
o Syncade
o Opcenter Execution Pharma
o PharmaSuite
• Experience with Power BI or manufacturing analytics tools.
• Experience working in cloud or hybrid manufacturing environments.
• Agile/Scrum delivery experience.